April 10, 2018

Opioid Withdrawal Drug Closer to Approval

The FDA’s Psychopharmacologic Drug Advisory Committee recently recommended Lucemyra (lofexidine), a drug developed to treat opioid withdrawal symptoms, for approval with an 11-1 vote. If approved, Lucemyra would be the first non-opioid drug available to treat the symptoms of opioid withdrawal.

Lucemyra suppresses neurochemical activity that triggers the painful symptoms of opioid withdrawal. The drug has completed Phase 3 clinical trials, including two randomized, double-blind placebo-controlled trials which found that individuals treated with Lucemyra were more likely to complete a seven-day opioid discontinuation treatment, and that they experienced less severe withdrawal symptoms.

The drug does appear to have some cardiac risks, which the dissenting voter felt could become an issue if the drug is not administered in the ideal conditions of a controlled clinical setting. Manufacturers originally hoped to push for a 3.2mg/day regimen, but the Committee made their recommendation for a 2.4mg/day regimen, with some flexibility allowed, to address the cardiac concerns.

Lucemyra received Priority Review status in November of 2017, expediting the drug review process. The FDA will now consider the Committee’s recommendation as it decides whether or not to approve the drug. A decision is expected sometime in second quarter of 2018.

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